Effect of Commercially Available Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children Aged 12-14 Years in Bangalore City (India): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- saliva samples were tested for CFU for streptococci mutans and lactobacilli
研究概览
简要总结
This study was conducted to assess the effects of commercially available probiotic drink on the number of salivary mutans streptococci in school going children, aged 12-14 years in Bangalore city in India
详细描述
Probiotic bacteria are thought to reduce the risk of diseases in oral cavity, namely dental caries. Studies have suggested that oral cavity can benefit immensely from these friendly bacteria, although more clinical trials are needed to establish concrete results. Hence, this study was undertaken as a 6 month clinical trial to assess the effects of probiotic on the most frequent resident of oral micro flora- the mutans streptococci.
Method- Design: parallel arm design Sample size: 60 subjects (30 subjects in each group) Duration: 6 months
Material used- Intervention/manipulation: 50ml commercially available probiotic drink for one group (30 subjects in study group) and 50 ml of plain, unsweetened and unflavored milk to control group (30 subjects in control group)for a period of 6 months.
Indices used: plaque index- Turskey Gilmore-Glikman modification of Quigley-Hein, Plaque Index (1970)
Gingival Index-Loe.H and Silness P. gingival index (1963)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no active carious lesion
- •restored dental cavities
- •on no systemic antibiotic medication 6 weeks before commencing the study
排除标准
- •habitual consumers of probiotics or xylitol chewing gums
- •recent exposure to topical/ systemic fluoride treatment
- •undergoing any orthodontic treatment during the entire study tenure
结局指标
主要结局
saliva samples were tested for CFU for streptococci mutans and lactobacilli
时间窗: feburary 2011 and july 2011 (6 months)
Saliva samples were tested and the results reveled that number of CFU for both streptococci mutans and lactobacilli varied significantly at the baseline and post intervention in study group (subjects who received probiotic drink). There was reduction in number of CFU of streptococci mutans and lactobacilli in study group.
次要结局
未报告次要终点
研究者
Dr. Aman deep Pabbla
assistant professor
The Oxford Dental College, Hospital and Research Center, Bangalore, India